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# FDA Says Medtronic Pump Recall is Class 1
- URL: https://www.fdaweb.com/fda-says-medtronic-pump-recall-is-class-1/
- Published: 2017-03-14T12:00:00.000Z
- Updated: 2026-09-14T22:11:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138196

FDA says that the Medtronic 9/2016 recall of its SynchroMed implantable infusion pumps due to a software problem that may cause unintended delivery of drugs during a priming bolus procedure is Class 1\. An agency [notice](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546623.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says the SynchroMed II and SynchroMed EL implantable infusion pumps are programmed to deliver prescribed drugs to a specific site inside a patient’s body. The pumps are used to treat primary or metastatic cancer, chronic pain, and severe spasticity, it says.

During a priming bolus procedure used to quickly deliver a large dose of medication from the device to the patient’s spine, FDA says, patients may receive the drug unintentionally at a high rate of infusion in the cerebrospinal fluid followed by a period of reduced drug delivery after the priming bolus. The agency says this can result in a drug overdose or under-dose, which can lead to serious adverse health consequences, such as respiratory depression, coma, or death.

The notice says that Medtronic sent an urgent medical device correction notice to affected customers 9/2016 with a description of the software change, description of labeling changes, software card recommendations, and new priming bolus recommendations. Company representatives began visiting affected customers 10/3/16 to install updated software application cards.